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The Motley Fool May 19, 2009 Brian Orelli |
Flip-Flopping: Not Just for Politicians Anymore The FDA's change is good for companies. |
The Motley Fool February 10, 2009 Brian Orelli |
Roses and Candy From the FDA? Some drugmakers expect the FDA to bestow its kiss of approval this month. Read on to see who. |
The Motley Fool May 20, 2010 Brian Orelli |
FDA Transparency! A Big Win for Investors The Food and Drug Administration has possibly just made things easier for investors. Let's just hope drug companies don't shoot it down. |
The Motley Fool December 24, 2009 Brian Orelli |
Another Reason to Worry About Pfizer The FDA fails to approve Lyrica for treating anxiety. |
The Motley Fool June 2, 2010 Brian Orelli |
Little Surprise. Big Stock Move. Investors like Amgen's early approval;shares are up 9% today, well ahead of the overall market. |
The Motley Fool February 11, 2009 Brian Orelli |
The FDA's Bipolar Decision Johnson & Johnson announces that the FDA has asked for more information before approving its application to market Risperdal Consta for frequently relapsing bipolar disorder. |
The Motley Fool February 16, 2010 Brian Orelli |
For Blockbuster Cancer Drugs, Approvals Are the Easy Part Don't get too excited. As an investor, you can lower your risk by investing in cancer drug companies after a clinical trial success but before an FDA approval, but you'll also reduce your reward. |
The Motley Fool June 16, 2011 Brian Orelli |
Are Two FDA Approvals in One Week a Positive Sign? Bristol-Myers Squibb received Food and Drug Administration approval for its kidney transplant drug Nulojix yesterday, marking the second approval this week from the FDA. |
The Motley Fool December 2, 2010 Brian Orelli |
A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying. |
The Motley Fool November 29, 2010 Brian Orelli |
There's Still Only One Merck KGaA's oral MS drug delay is Novartis' gain. |
The Motley Fool November 27, 2007 Brian Orelli |
Second Chance for Merck's MEVACOR Merck licenses the rights to an over-the-counter version of its cholesterol-lowering drug MEVACOR to GlaxoSmithKline, but the deal is far from done. Investors, take note. |
The Motley Fool July 1, 2008 Brian Orelli |
As the FDA Generics Office Turns The FDA reluctantly gives Teva a 180-day exclusive period to sell generic Risperdal. |
The Motley Fool March 13, 2009 Brian Orelli |
Will These Drugs Get Past the FDA? Let's take a look at which pharma companies are hoping to score with the FDA this month. |
The Motley Fool February 25, 2011 Brian Orelli |
When the Companies Know, Investors Should, Too Why don't more companies preannounce FDA rejections? |
The Motley Fool January 31, 2011 Brian Orelli |
5 Drugmakers Headed Back to the Drawing Board Sometimes an FDA rejection is more of a to-do list. |
The Motley Fool August 27, 2008 Brian Orelli |
Another FDA Setback for Johnson & Johnson The company has to wait for an approval of its extended-release schizophrenia drug. Investors, take note. |
The Motley Fool November 17, 2010 Brian Orelli |
52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval. |
The Motley Fool March 8, 2010 Brian Orelli |
Really? A 59% Share Price Jump for That? Justified or not, InterMune skyrockets ahead of an FDA panel meeting. |
The Motley Fool August 24, 2009 Brian Orelli |
J&J Would Rather Not Say Drug delayed, reason unknown. Should shareholders be worried? It's hard to tell. |
The Motley Fool January 21, 2011 Brian Orelli |
Mark Your Calendar, Drug Investors Vertex announces that the Food and Drug Administration has accepted its New Drug Application to market telaprevir. |
The Motley Fool April 28, 2011 Brian Orelli |
Victory for Victrelis Merck's hepatitis C drug moves one step closer to FDA approval. |
The Motley Fool September 9, 2010 Brian Orelli |
Will These Drugs Get Past the FDA This Month? See what the FDA has on its decision calendar for the rest of September. |
The Motley Fool February 18, 2010 Brian Orelli |
Still Restless for an Approval The FDA is like a box of chocolates: You never know what you're going to get -- rejection or acceptance. |
The Motley Fool May 29, 2009 Brian Orelli |
Delayed, Reason Unknown As long as Bayer and Johnson & Johnson can answer the FDA's questions relatively quickly, it shouldn't affect the companies too much. |
The Motley Fool June 25, 2010 Brian Orelli |
Mark Your Calendars: Obesity Drugs Take Center Stage Orexigen Therapeutics has been given an FDA advisory committee meeting date, completing the dates for the trio of obesity drugs up for review. |
The Motley Fool December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
The Motley Fool December 28, 2010 Brian Orelli |
Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson. |
The Motley Fool July 30, 2010 Brian Orelli |
A Faster Pathway to Drug Approvals A thinktank called the Pacific Research Institute has proposed letting drugs approved by the European Medicines Authority onto the market in the U.S. before the Food and Drug Administration has approved the drugs. |
The Motley Fool March 10, 2010 Brian Orelli |
Up 160% With Room to Run You've got to love biotech and InterMune. |
The Motley Fool December 31, 2009 Brian Orelli |
2010 FDA Decisions to Watch It's a pivotal year for these drugmakers. |
The Motley Fool June 17, 2010 Brian Orelli |
Merck Needs to Get Busy While waiting for the FDA to approve the expanded age range, sales of Merck's Gardasil have gone to sleep. |
The Motley Fool December 27, 2010 Brian Orelli |
FDA Kicks Dust on Alimera's Fairy Tale Eight months after its IPO, Alimera gets hammered. |
The Motley Fool December 22, 2003 Alyce Lomax |
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired. |
The Motley Fool May 27, 2010 Brian Orelli |
This Rabid Agency Could Permanently Damage Your Portfolio The FDA has gotten a little out of control. The wonkiness of the FDA's actions makes it hard for investors to figure out what the agency will do. |
The Motley Fool October 5, 2011 Brian Orelli |
1 Sure Sign of an FDA Approval Transcept Pharmaceuticals shoots up 34% after announcing that the FDA had classified its resubmission as a class 1 response. |
The Motley Fool March 23, 2010 Brian Orelli |
No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma. |
The Motley Fool July 1, 2008 Brian Lawler |
FDA News Gives Glaxo a Glimmer of Hope Approval is delayed, but new studies won't be needed for Cervarix. |
The Motley Fool April 7, 2011 Brian Orelli |
Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market. |
The Motley Fool March 31, 2011 Brian Orelli |
Drug Warning Labels: The Good, Bad, and Ugly Once a drug is approved, investors can't fall asleep and ignore FDA announcements about drugs. They come in different varieties, but warnings tend to be of the bad and ugly variety more often than the good. |
The Motley Fool August 10, 2010 Brian Orelli |
When the Disease Matters Most in Drug Approval Glaxo's and Valeant's Potiga will go before an FDA advisory committee tomorrow. |
The Motley Fool June 18, 2010 Brian Orelli |
Double the Approvals! Double the Fun! These twins will take it. sanofi-aventis and Novartis both received FDA approvals for their cancer drugs yesterday. |
The Motley Fool March 3, 2009 Brian Orelli |
A Tale of 2 Weeks It's been a busy two weeks at Genzyme as two nasty notes from the FDA follow two approvals. |
The Motley Fool April 5, 2010 Brian Orelli |
1 Month to Go! Is Dendreon a Buy? Only if you understand the risks. |
The Motley Fool October 19, 2010 Brian Orelli |
Why the FDA Won't Approve Lorcaserin and Qnexa (Yet) Obesity drugs get their day in front of the agency. |
The Motley Fool September 15, 2008 Brian Orelli |
Teva and FDA's Never-Ending Court Battle The Food and Drug Administration has won the latest installment of its grudge match with Teva Pharmaceuticals over the 180-day exclusivity period for generic versions of Johnson & Johnson's Risperdal. |
The Motley Fool August 17, 2007 Brian Orelli |
Fewer Drug Approvals? Buy! Stricter standards at the FDA could create a buying opportunity. Drug approvals are down one third this year, creating a lot of value in pharmaceutical and biotech companies. Just choose your medicines carefully. |
The Motley Fool April 14, 2008 Brian Orelli |
Teva Gets What It Wants Teva persuades a court to order the FDA to award it a marketing exclusivity for generic Risperdal. |
The Motley Fool May 26, 2009 Brian Orelli |
When Higher Costs Are a Good Thing The Food and Drug Administration proposed its budget for the next fiscal year, including user fees for pharmaceutical companies. But GlaxoSmithKline, Merck, and the rest of the industry probably won't complain too loudly. |
The Motley Fool December 8, 2010 Brian Orelli |
Up 100% With Room to Fly Orexigen gets a positive FDA panel nod. |
The Motley Fool November 14, 2007 Brian Lawler |
Is the FDA Still Approving New Drugs? Lately the FDA seems more reluctant to approve new drugs than it once was. Let's take a look at the actual numbers from the past eight years. |